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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTER-FERENCE SCRW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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ARTHREX, INC. BIO-COMP INTER-FERENCE SCRW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE Back to Search Results
Catalog Number AR-5028C-08
Device Problems Difficult or Delayed Positioning (1157); Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2016
Event Type  Injury  
Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device was not returned for evaluation.
 
Event Description
It was reported that the screw was hard to apply to the screwdriver.When inserting the screw into the bone, screw broke at proximal end.Proximal end of screw protruded about 14 mm from bone and needed to be impacted and bent into knee.Surgery performed was an acl reconstruction.Broken proximal fragment was retrieved.Surgery was successfully completed using another screw of the same type.
 
Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed that a portion of the screw's distal tip was broken off at approximately the 5th thread.The fracture surface displays evidence of torsional-overload.In addition, the screw and it's hex are deformed and damaged.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging, improper bone preparation or flexing the joint during insertion.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
 
Event Description
It was reported that the screw was hard to apply to the screwdriver.When inserting the screw into the bone, screw broke at proximal end.Proximal end of screw protruded about 14 mm from bone and needed to be impacted and bent into knee.Surgery performed was an acl reconstruction.Broken proximal fragment was retrieved.Surgery was successfully completed using another screw of the same type.
 
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Brand Name
BIO-COMP INTER-FERENCE SCRW
Type of Device
FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath, sr mdr analyst
1370 creekside boulevard
naples, FL 34108-1945
8009337001
MDR Report Key6022077
MDR Text Key57153815
Report Number1220246-2016-00417
Device Sequence Number1
Product Code MAI
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K071176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 11/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/01/2018
Device Catalogue NumberAR-5028C-08
Device Lot Number10050923
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received11/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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